System and process for tobaccoless nicotine delivery

ABSTRACT

A tobaccoless nicotine delivery device permits delivery of nicotine in a manner similar to a cigarette. The device may include an impermeable outer layer surrounding a micro-encapsulated nicotine layer that includes a measured amount of nicotine in a form that allows nicotine vapor to be released upon rupture of the micro-encapsulation. A permeable membrane may be disposed adjacent to the micro-encapsulated nicotine layer that allows pressure to be applied to the micro-encapsulated nicotine layer while permitting permeation of released nicotine into a central channel for inhalation by a user. A mouthpiece may be disposed at an open end of the central channel in order to provide air resistance to simulate the inhalation effect of a cigarette.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Prov. Appl. No. 60/992,217, filed Dec. 4, 2007, the entire content of which is incorporated herein by reference.

BACKGROUND

1. Field

The present invention relates to a system and method for tobaccoless nicotine delivery.

2. Description of the Related Art

Current nicotine phase out systems utilize devices do not closely resemble the actual system and act of smoking. Completely eliminating the tactile and habitual sensations that are part of the cigarette experience may delay the adoption of the therapy by habitual smokers. For example, the nicotine patch completely removes the tactile sensation of the hand-to-mouth motion of smoking. Certain nicotine inhalation devices use a system that resembles a cigarette but are composed of materials that do not look or feel like cigarettes, such as plastic mouthpieces and metallic or plastic cartridges.

Thus, a need exists for a smoking cessation therapy comprising a nicotine replacement or phase out device that more closely resembles a cigarette and the experience of smoking a cigarette.

These and other systems, methods, objects, features, and advantages of the present invention will be apparent to those skilled in the art from the following detailed description of the preferred embodiment and the drawings.

SUMMARY

A tobaccoless nicotine delivery device permits delivery of nicotine in a manner similar to a cigarette. The device may include an impermeable outer layer surrounding a micro-encapsulated nicotine layer that includes a measured amount of nicotine in a form that allows nicotine vapor to be released upon rupture of the micro-encapsulation. A permeable membrane may be disposed adjacent to the micro-encapsulated nicotine layer that allows pressure to be applied to the micro-encapsulated nicotine layer while permitting permeation of released nicotine into a central channel for inhalation by a user. A mouthpiece may be disposed at an open end of the central channel in order to provide air resistance to simulate the inhalation effect of a cigarette.

All documents mentioned herein are hereby incorporated in their entirety by reference. References to items in the singular should be understood to include items in the plural, and vice versa, unless explicitly stated otherwise or clear from the text. Grammatical conjunctions are intended to express any and all disjunctive and conjunctive combinations of conjoined clauses, sentences, words, and the like, unless otherwise stated or clear from the context.

BRIEF DESCRIPTION OF THE FIGURES

The invention and the following detailed description of certain embodiments thereof may be understood by reference to the following figures:

FIG. 1 shows a nicotine delivery device.

FIG. 2 shows a cross-sectional view of a nicotine delivery device.

FIG. 3 depicts a process for delivering nicotine from a nicotine delivery device.

FIG. 4 shows a nicotine delivery device using miniature nozzles to aerosolize nicotine.

FIG. 5 shows a nicotine delivery device using miniature nozzles to aerosolize nicotine.

DETAILED DESCRIPTION

Disclosed herein are systems and methods directed to tobaccoless nicotine delivery. The invention disclosed herein is a drug delivery device that delivers nicotine in a form factor similar to a cigarette but with no smoke, heat, or tobacco. This nicotine experience encourages the familiar and important social interactions that cigarettes generate including familiar tactile, oral, and visual interactions. However, the majority of the nicotine is delivered not to the lungs but to the oral and buccal cavity through which thereafter nicotine gets systemically distributed.

FIG. 1 shows a nicotine delivery device. In general, the nicotine delivery device 100 may be shaped and sized to resemble a cigarette or the like. An impermeable outer layer 102 of the nicotine delivery device 100, which may be substantially cylindrical in shape and generally impermeable to nicotine, may include graphics or other visual content. The outer layer 102 may comprise paper, fabric, plastic, metal, or any suitable material. The outer layer 102 may be formed from similar materials as is found in a typical cigarette. The outer layer 102 may be colored to resemble a cigarette. The outer layer 102 may form a part of a vapor barrier so that nicotine contained within the device 100 can not escape to the atmosphere.

FIG. 2 shows a cross-sectional view of the nicotine delivery device 100 and FIG. 3 depicts a process for delivering nicotine from the nicotine delivery device 100.

In an embodiment, a layer 104 of micro-encapsulated nicotine may be disposed adjacent to the impermeable outer layer 102. The nicotine 108 may comprise any form of nicotine, such as the nicotine free base, i.e., (S)-3-(1-Methyl-2-pyrrolidinyl)pyridine, a compound having the formula C₁₀H₁₄N₂, “nicotine salt”, which refers to any mono- or bis-pharmaceutically acid addition acceptable salt or metal salt of nicotine, “pharmaceutically acceptable acid addition salt”, which refers to those salts which retain the biological effectiveness and properties of the free bases and which are not biologically or otherwise undesirable, formed with inorganic acids such as hydrochloric acid, hydrobromic acid, sulfuric acid, nitric acid, phosphoric acid and the like, and organic acids such as acetic acid, propionic acid, glycolic acid, pyruvic acid, oxalic acid, malic acid, malonic acid, succinic acid, maleic acid, fumaric acid, tartaric acid, citric acid, benzoic acid, cinnamic acid, mandelic acid, menthanesulfonic acid, ethanesulfonic acid, p-toluenesulfonic acid, salicylic acid and the like (For a description of pharmaceutically acceptable acid addition salts, see Bundgaard, H., ed., (1985) Design of Prodrugs, Elsevier Science Publishers, Amsterdam); and “pharmaceutically acceptable metal salt”, which refers to those salts which retain the biological effectiveness and properties of the free bases and which are not biologically or otherwise undesirable, formed with alkali metal ions such as sodium or potassium; alkaline earth metal ions such as calcium and magnesium; and other metal ions such as zinc.

A structure 109 (which is shown in even greater detail in FIG. 3) such as a micro-encapsulation structure may be designed to hold a precise amount of nicotine 108 in a form that will allow a nicotine vapor (see FIG. 5) to be released into a fluid stream passing around or through the layer 104. The structure 109 may enclose the nicotine 108 in a nicotine-impermeable barrier or other nicotine-retaining layer that may be ruptured by finger pressure (as indicated by an arrow 110) to release the nicotine 108. The structure 109 may include excipients, flavorants, nicotine-impermeable polymers and plastics, oleaginous substances (fats and oils), saccharides, proteins and other non-toxic polymeric material, co-crystallization, and so forth. The structure 109 may encapsulate the nicotine 108 as nanoparticles in liposomes or using other encapsulating methods, and the like. In various embodiments, the nicotine 108 may be in any phase form, such as solid, liquid, or gaseous.

In an embodiment, the nicotine 108 may be encapsulated in a gaseous soluble form, such as vaporized free base nicotine. The encapsulation may also be in the form of micro-spheres. The structure 109 surrounding the nicotine 108 may rupture with an applied pressure (as indicated by an arrow 110), which may include a finger pressure applied by someone holding the device 100, or flow-induced or suction pressure created by inhalation on the device 100, thus allowing the nicotine 108 to escape and enter a central channel 112 (see FIG. 2) of the nicotine delivery device where it may be delivered by inhalation to a user. The impermeable outer layer 102 may inhibit the nicotine 108 from escaping the nicotine delivery device 100 should the nicotine migrate away from the central channel 112.

An inner layer 120 may be positioned adjacent to the layer 104 of micro-encapsulated nicotine. The inner layer 120 may be substantially cylindrical and coaxial with the outer layer 102, and may provide a permeable and structural inner layer that provides a solid base against which to apply exterior force to the device 100 in order to release nicotine 108 from the layer 104 of micro-encapsulated nicotine. As a result, the nicotine 108 may permeate the inner layer 120 and enter the central channel 112 for inhalation. The inner layer 120 may include any gas-permeable material, such as paper, perforated plastic, polymers, and the like, as well as various combinations of these. In general, the outer layer 102 may yield upon application of a predetermined amount of pressure and the inner layer 120 may not yield (e.g., remains rigid) upon application of the predetermined amount of pressure to the outer layer, so that the structure 109 of the intermediate layer 104 ruptures and releases the nicotine 108.

In an embodiment, the inner layer 120 may be permeable to ambient air. For example, when a user wishes to use the device, they may remove a cover that permits the exposure of the central channel 112 to air, either through an open end 105 of the device 100, or through a porous region 107 of the outer layer 102 (which may be covered by a cap when the device 100 is not in use). In an embodiment, the central channel 112 may be capped on an inhaling end by a filter element 114 or other porous element. The filter element 114 may provide air resistance to simulate the inhalation effect of a cigarette but may be permeable to nicotine 108 released within the central channel 112. The filter element 114 may also provide a medium for inclusion of flavorants to flavor the nicotine 108 as it passes through the filter element 114. For example, the flavorant may be menthol, tobacco, or any other flavor. In an embodiment, the filter element 114 may be a detachable element. When a user wishes to use the nicotine delivery device 100, they may attach a filter element 114 corresponding to the flavorant of their choosing. The filter element 114 may be changed during use to allow a user to try different flavorings. In an embodiment, the filter element 114 may be attached to any nicotine inhalation device, cigarette, cigar, and the like to provide flavoring.

In an embodiment, the central channel 112 may be capped by a one way valve 118 or other flow restrictor to restrict the intake of nicotine upon inhalation. The one way valve 118 may provide a user with a sensation of inhaling a cigarette by restricting air flow in a manner similar to a cigarette filter. In an embodiment, the one way valve 118 may take the place of the filter element 114 or work with the filter element 114 in capping the end of the nicotine delivery device. In any event, a mouthpiece 122 may be placed on the end of the filter element 114 or one way valve 118. The user may rupture the structure 109 surrounding the nicotine 108 in the layer 104 of micro-encapsulated nicotine as generally described above, and then during or after this rupturing, inhale using the mouthpiece. In operation, inhalation may draw air (e.g., through the porous region 107 of the outer layer 102, or through an open end 105 of the central channel 112), and with it, nicotine 108 from the layer 104 of micro-encapsulated nicotine, into the mouth of the user from where it may be systemically distributed.

Referring to FIG. 4 and FIG. 5, the nicotine delivery device 100 may include a plurality of micro-nozzles 202 for aerosolizing nicotine 108 for ingestion and/or inhalation. The micro-nozzles 202 may be disposed as a layer disposed within the outer layer 102 of the device 100. As pressure is applied on the outer layer 102 (as shown in an arrow 410 in FIG. 5), the nicotine 108 may be released from the structure 109 as a nicotine vapor and enter a micro-nozzle 202 in which the nicotine becomes aerosolized. The aerosolized nicotine may enter the central channel 112 directly from the micro-nozzles 202 or it may first have to permeate a permeable inner layer such as the inner layer 120 described above, which may or may not be present in addition to the micro-nozzles 202. In some embodiments, the micro-nozzles 202 may form the inner layer 120.

Thus it will be appreciated that there is generally described herein a tobaccoless nicotine delivery device and a method for using same to orally deliver nicotine to a user in a manner similar to smoking a cigarette. It will be appreciated that the various steps identified and described above may be varied, and that the order of steps may be adapted to particular applications of the techniques disclosed herein. All such variations and modifications are intended to fall within the scope of this disclosure. As such, the depiction and/or description of an order for various steps should not be understood to require a particular order of execution for those steps, unless required by a particular application, or explicitly stated or otherwise clear from the context.

While the invention has been disclosed in connection with the preferred embodiments shown and described in detail, various modifications and improvements thereon will become readily apparent to those skilled in the art. Accordingly, the spirit and scope of the present invention is not to be limited by the foregoing examples, but is to be understood in the broadest sense allowable by law.

All documents referenced herein are hereby incorporated by reference. 

1. A tobaccoless nicotine delivery device comprising: an outer layer, the outer layer being substantially cylindrical and impermeable to nicotine; an inner layer, the inner layer being substantially cylindrical and permeable to nicotine, the inner layer contained within and substantially coaxial to the outer layer; a micro-encapsulation layer between the inner layer and the outer layer, the micro-encapsulation layer including a structure that encapsulates nicotine, the structure adapted to rupture upon an application of pressure thereby releasing the nicotine; and a central channel within the inner layer; and a mouthpiece disposed at the end of the central channel and coupled thereto, whereby a user may inhale on the mouthpiece to draw air through the central channel to receive the nicotine therein when the nicotine is released from the micro-encapsulation layer.
 2. The device of claim 1 further comprising a filter element disposed between the mouthpiece and an end of the central channel, the filter element providing air resistance to simulate an inhalation effect of a cigarette.
 3. The device of claim 2 further comprising a flavorant within the filter element, the flavorant providing a flavor to air passing therethrough.
 4. The device of claim 2 wherein the filter element is detachable.
 5. The device of claim 4 wherein the filter element can be attached to at least one of a cigarette, a cigar, and a nicotine delivery device.
 6. The device of claim 1 further comprising a one way valve disposed between the mouthpiece and an end of the central channel for restricting a passage of nicotine during inhalation.
 7. The device of claim 1 wherein the outer layer yields upon application of a predetermined pressure and the inner layer does not yield upon application of the predetermined pressure, the micro-encapsulation layer rupturing to release the nicotine upon an application of the predetermined pressure thereto, whereby the nicotine is released upon an application of the predetermined pressure to the outer layer.
 8. The device of claim 1 wherein the structure is adapted to rupture upon an application of pressure to the outer layer.
 9. The device of claim 1 wherein the structure is adapted to rupture upon an inhalation through the mouthpiece of the device.
 10. The device of claim 1, wherein the micro-encapsulation layer further includes at least one of an excipient, a flavorant, a nicotine-impermeable polymer, a nicotine-impermeable plastic, an oleaginous substance, a saccharide, a protein, a polymeric material, a co-crystal, and a liposomal nanoparticle.
 11. A method of fabricating a tobaccoless nicotine delivery system comprising: providing a micro-encapsulated nicotine layer in a substantially cylindrical shape that includes a measured amount of nicotine within a structure that allows the nicotine to be released as a nicotine vapor when the structure is ruptured; surrounding the micro-encapsulated nicotine layer with an impermeable outer layer; disposing a permeable membrane inside the micro-encapsulated nicotine layer with a central channel therethrough, the permeable membrane adapted to allow permeation of the nicotine vapor to the central channel; and disposing a mouthpiece at an open end of the central channel.
 12. The method of claim 11 further comprising disposing a filter element in between the mouthpiece and the open end of the central channel.
 13. The method of claim 12 further comprising distributing a flavorant within the filter element.
 14. The method of claim 12 wherein the filter element is detachable.
 15. The method of claim 14 wherein the detachable filter element can be attached to at least one of a cigarette, a cigar, and a nicotine delivery device.
 16. The method of claim 11 further comprising disposing a one way valve in between the mouthpiece and the open end of the central channel that restricts a passage of nicotine therethrough.
 17. The method of claim 11 wherein the micro-encapsulation comprises at least one of an excipient, a flavorant, a nicotine-impermeable polymer, a nicotine-impermeable plastic, an oleaginous substance, a saccharide, a protein, a polymeric material, a co-crystal, and a liposomal nanoparticle.
 18. A tobaccoless nicotine delivery device, comprising: an impermeable outer layer surrounding a micro-encapsulated nicotine layer, the micro-encapsulated nicotine layer including a measured amount of nicotine in a structure that allows a nicotine vapor to be released upon a rupture of the structure; a plurality of micro-nozzles disposed adjacent to the micro-encapsulated nicotine layer, wherein the nicotine vapor becomes aerosolized as it passes through the plurality of micro-nozzles to a central channel of the tobaccoless nicotine delivery device; and a mouthpiece disposed at an open end of the central channel.
 19. The device of claim 18 further comprising a filter element disposed in between the mouthpiece and the end of the central channel.
 20. The device of claim 19 wherein the filter element provides air resistance to simulate an inhalation effect of a cigarette. 